CAPTAIN-T2D remains on track, with topline data from the original and expansion cohorts expected by end-of-year (EOY) 2027 to enable pivotal Phase 3 readiness
Boston, Massachusetts, November 5, 2026 — Sparrow Pharmaceuticals, a targeted cardiometabolic therapeutics company, today announced the addition of expansion cohorts to the ongoing Phase 2b CAPTAIN-T2D trial (NCT07296484) of clofutriben, a novel, once-daily, oral HSD-1 inhibitor, in patients with difficult-to-control (DTC) type 2 diabetes (T2D). HSD-1 inhibition lowers intracellular cortisol, a biological target that today’s standards of care do not address. The original, dose-ranging cohorts of CAPTAIN-T2D are enrolling up to approximately 210 patients with post-dexamethasone suppression test (DST) cortisol greater than 1.8 µg/dL. The expansion cohorts will enroll approximately 80 additional patients with post-DST cortisol at or below 1.8 µg/dL to evaluate whether clofutriben’s efficacy benefits and safety extend across the entire range of cortisol levels in inadequately controlled T2D.
Cortisol is an underrecognized driver of treatment resistance and comorbidities in cardiometabolic disease. Interim data from CAPTAIN-T2D, presented at ENDO 2026, showed that among 397 DTC T2D patients screened, 77.1% had post-DST cortisol ≥0.9 µg/dL, a level that has been reported to be associated with an increased prevalence of cardiovascular disease. Multiple studies have identified post-DST cortisol lower than 1.8 µg/dL as being associated with increased cardiometabolic morbidity and adverse outcomes1,2,3,4,5. A cortisol-directed agent benefited patients with treatment-resistant T2D and post-DST cortisol greater than 1.8 µg/dL6. However, this is the first time that a cortisol-directed agent has been tested in DTC T2D in patients with lower post-DST cortisol.
“The 1.8 µg/dL threshold was not developed to predict response to cortisol-directed antihyperglycemic therapy,” commented Frank Czerwiec, M.D., Ph.D., Chief Medical Officer of Sparrow Pharmaceuticals. “Cortisol is critical to glucose regulation in everyone with T2D. By evaluating clofutriben in patients across the entire range of post-DST cortisol levels, CAPTAIN-T2D may help us to identify a better threshold, or to understand if clofutriben can have meaningful benefits across the entire population of inadequately controlled T2D.”